PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.

Summary

Informal cancer caregivers are individuals (usually family members or friends) who manage patient care which is typically uncompensated and delivered at home, involves significant amounts of time and energy, and requires the performance of tasks that may be physically, emotionally, socially, or financially demanding. These tasks include monitoring for treatment side effects, helping manage symptom burden, treatment decision-making, administering medication, and performing technical medical tasks (e.g., managing infusion ports, changing dressings). Despite these demands, caregivers are often underprepared to perform the many tasks required of them. Simultaneously, cancer treatment is more frequently provided in outpatient and community-based centers, which increases the day-to-day demands on informal caregivers.

Technology offers the potential of mitigating these demands and alleviating distress and burden for caregivers by offering decision-making tools, strategies for managing and communicating symptoms with providers, assistance with technical medical tasks, and care coordination. Furthermore, a majority of caregivers endorse the idea that technology may aid in preventing burnout and may reduce financial burden on both families and the healthcare system. Despite this, there is a lack of evidence-driven technologies to ease cancer caregiving burden available on the market.

The purpose of the proposed concept is to develop evidence-based technologies to alleviate cancer caregiving burden, assist family/informal caregivers to manage the needs of their care recipients, juggle their own healthcare needs, and enhance caregivers’ connections with their care recipients’ healthcare team. The SBIR mechanism is ideally suited to support this activity because it pairs investigators with software developers to create evidence-based technologies that can be scaled and disseminated with wide reach.

Purpose & Goals

The overall goal of this project is to develop software, database systems and mobile application tools to support cancer caregivers and connect them with their patients’ care teams. These systems will enhance care quality and effectiveness and will allow care delivered beyond clinic walls into the home setting, ultimately aiming to improve patient outcomes. Systems should be designed to be flexible and customizable, to be modified based on feedback from patients, caregivers, or providers, and to evolve as patient and caregiver needs evolve. Development should utilize an iterative, user-centered design approach informed by actual cancer patients, caregivers, and healthcare providers.

A recent environmental scan of technological resources available to informal cancer caregivers was performed to determine current available software systems and capabilities. The following caregiving support categories were identified based on previous reviews in the topic area: consultation and clinical care delivery, medical skills training, therapy/counseling, financial resources, and peer-to-peer support. Of the ten software systems identified, none provided support in all areas (most provided support in only 1-2 areas). Many of the cancer-focused apps identified targeted patients only; only three targeted caregivers. None of the systems identified directly connected cancer caregivers back to the patients’ healthcare provider team or associated electronic health record (EHR) and patient portals.

The following are specific modules that the caregiving platform should consider:

The development of a software system with mobile application to connect cancer patients and their caregivers with healthcare provider teams to extend clinical interactions and provide further information resources and service referral. Key task domains should include organization-level (hospital or clinic), provider-level, caregiver-level, and patient-level dashboards that allow for assessment of adherence to treatment and post-treatment clinical practice guidelines, capability to identify high-risk patients, ability to identify care gaps and enable clinical data query functions.

The development of secure bi-directional communication system to allow healthcare providers and authorized caregivers to push messages, including adjustments to the care plan, directly through the system.

The development and testing of a prototype of a platform and caregiver-facing applications to be tested with cancer caregivers, patients and caregiving researchers.

Further enhancement and refinement of the software system and mobile application.

A provider/ clinic health system dashboard to be able to communicate with the caregiver and download and upload information and integrate that information with electronic health records where possible and appropriate

A caregiver application and dashboard to be able to communicate with provider and download and upload information

A function within the application that allows the caregiver to communicate with other caregivers within the network of caregivers on the application "community"

A dashboard/database that would communicate to caregivers, patients, and providers about community resources

Data and security standards for collection, transport, and storage of data inputs that ensure patient and caregiver privacy following standard NIH policies.

Data visualization, feedback and reporting systems for clinical monitoring and research applications

Present Phase I findings and demonstrate functional prototype to an NCI evaluation Panel

Phase II Activities and Deliverables

Establish a project team for Phase II activities and outcomes. This team should include personnel with training and research experience in chronic disease patient clinical trial or intervention design, implementation, and statistical methods for validation/evaluation as appropriate for the proposed project. Provide a report outlining team member credentials, specific project roles, and timelines for performance.

Evaluate specific IT customization requirements to support hardware, software, or communications system integration of the technology into the target clinical, health system or service, or other relevant software environment in preparation for validation. Provide a report documenting the specific IT customization requirements and timelines for implementation.

Evaluate, enhance as necessary and provide documentation that the technology and communications systems maintain compliance with HIPAA, data security, privacy, and consent management protocols as required for the proposed project.

Test the integration of the technology into the target clinical, health system or service, or other relevant software environment in preparation for validation. Provide a report documenting the results of system testing and timelines for trouble-shooting.

Develop user support documentation to support all applicable potential users of the technology, including but not limited to patients/consumers, family/caregivers, and providers. Provide a report documenting user support resources, including but not limited to, links to online resources and copies of electronic or paper user support resources as appropriate.